Identification and isotyping of monoclonal immunoglobulin heavy (IgD and IgE) and light chains
Documentation of complete response to therapy
Immunofixation
Heavy Chain proteins
Immunofixation (IEP)
Immunoelectrophoresis (IFE)
Immunosubtraction
Macroglobulins
Monoclonal protein study
Myeloma study
Protein analysis, myeloma
Serum
Patient Preparation: Fasting preferred but not required
Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Specimen Volume: 1 mL
See Specimen Required
Gross hemolysis | OK |
Gross lipemia | OK |
Gross icterus | OK |
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Serum | Refrigerated (preferred) | 28 days | |
Frozen | 28 days | ||
Ambient | 14 days |
Identification and isotyping of monoclonal immunoglobulin heavy (IgD and IgE) and light chains
Documentation of complete response to therapy
Monoclonal gammopathies indicate a clonal expansion of plasma cells or mature B lymphocytes and, rarely, may consist of IgD or IgE immunoglobulin heavy chains. The monoclonal gammopathies of such diseases include multiple myeloma, primary systemic amyloidosis, light-chain deposition disease, as well as the premalignant disorders of smoldering myeloma and monoclonal gammopathy of undetermined significance (MGUS). Monoclonal gammopathy patients may have a relatively small monoclonal protein abnormality or a large quantifiable peak (ie, M-spike) on serum or urine protein electrophoresis.
Abnormalities detected on serum protein electrophoresis (SPEP) should have immunotyping performed to confirm and characterize the monoclonal protein. Immunotyping of monoclonal proteins is usually done by immunofixation electrophoresis (IFE), which identifies the monoclonal immunoglobulin heavy-chain (gamma, alpha, mu, delta, or epsilon) and/or light-chain type (kappa or lambda). It is generally recommended that both SPEP and IFE be used as a screening panel. Because IFE is more sensitive than SPEP, IFE is not only recommended as part of the initial screening process but also for confirmation of complete response to therapy. Patients that have only lambda or kappa light chain results from traditional IgG, IgA, and IgM assays, should have kappa and lambda IFE performed using anti-sera against IgD and IgE to accurately isotype the M-protein.
Immunofixation Delta and Epsilon: No monoclonal IgD or IgE protein detected.
Immunofixation Delta and Epsilon, Flag: Negative
Immunofixation impression comments are made based on visual interpretation of gels.
Immunofixation is not a quantitative assay. If a monoclonal protein is identified, a serum protein electrophoresis assay is required for quantifying the abnormality.
1. Willrich MAV, Murray DL, Kyle RA: Laboratory testing for monoclonal gammopathies: Focus on monoclonal gammopathy of undetermined significance and smoldering multiple myeloma. Clin Biochem. 2018 Jan;51:38-47
2. Sykes E, Posey Y: Immunochemical characterization of immunoglobulins in serum, urine, and cerebrospinal fluid. In: Detrick B, Schmitz JL, Hamilton RG eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. ASM Press; 2016:89-100
3. Katzmann JA, Kyle RA: Immunochemical characterization of immunoglobulins in serum, urine, and cerebrospinal fluid. In: Detrick B, Hamilton RG, Folds JD eds. Manual of Molecular and Clinical Laboratory Immunology. 7th ed. ASM Press; 2006:88-100
4. Keren DF, Humphrey RL: Clinical indications and applications of serum and urine protein electrophoresis. In: Detrick BD, Hamilton RG, Schmitz JL eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. 2016:74-88
5. Katzmann JA, Keren DF. Strategy for detecting and following monoclonal gammopathies. In: Detrick BD, Hamilton RG, Schmitz JL, eds. Manual of Molecular and Clinical Laboratory Immunology. 8th ed. ASM Press; 2016:112-124
Immunofixation is performed with reagents specific for delta and epsilon immunoglobulin heavy chains and kappa and lambda light chains. Immunofixation electrophoresis is performed in four stages: 1) separation of proteins by electrophoresis on an agarose gel; 2) immunofixation (immunoprecipitation) and fixation of the electrophoresed proteins;3) removal of unprecipitated soluble proteins by blotting and washing; and 4) staining of the precipitated proteins for visualization.(Package insert: HYDRAGEL 1, 2, 4 and 9 IF kit. Sebia Inc; 07/2020)
Monday through Friday
This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.
86334
Test Id | Test Order Name | Order LOINC Value |
---|---|---|
IFXED | Immunofixation Delta and Epsilon, S | In Process |
Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
---|---|---|
606458 | Immunofixation D and E | 74665-1 |
606981 | Flag, Immunofixation D and E | No LOINC Needed |